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Over 2,000 people have been recruited into the world’s largest clinical trial to test the clinical and cost effectiveness of the flu drug oseltamivir (Tamiflu) in primary care

The HRB Primary Care Clinical Trials Network Ireland, based at NUI Galway, are working with researchers in Oxford University’s Nuffield Department of Primary Care Health Sciences, on the ALIC4E trial, which investigates whether the flu drug oseltamivir (Tamiflu) is cost effective and beneficial to patients consulting their GP’s with flu symptoms.

In particular, the study aims to understand if older people, infants, people with other health conditions, those treated early, or those with particularly severe flu can benefit from the treatment.

Over 2,000 people have been recruited into the world’s largest clinical trial to test the clinical and cost effectiveness of the flu drug oseltamivir in primary care. The trial aims to address the widespread uncertainty over whether people with flu symptoms should be treated with antiviral drugs in the community. To date, 45 patients from Ireland have participated in this trial, recruited from five practices within the HRB Primary Care Clinical Trials Network Ireland.

ALIC4E is the first publicly-funded randomised controlled trial of its kind to assess antiviral treatment for influenza in primary care and it aims to recruit a total of 4,500 participants across 16 countries, including Ireland.

The antiviral oseltamivir is a member of a class of drugs called neuraminidase inhibitors. These drugs are stockpiled and recommended by public health agencies worldwide for treating and preventing severe outbreaks of seasonal and pandemic influenza, yet some experts suggest the evidence supporting their use is lacking. The drug was widely used during the ‘swine flu’ pandemic, for example, but no trial was carried out on its clinical and cost effectiveness.

HRB Primary Care Clinical Trials Network Ireland Director, Professor Andrew Murphy at NUI Galway, said: “It is important that primary care patients and GPs in Ireland have the opportunity to contribute data to important international trials. We are delighted to see our Network practices recruiting patients into this clinical trial.”

GP’s and practice nurses in five practices in Ireland are currently recruiting patients at Turloughmore Medical Centre and Main Street Clinic Loughrea in County Galway, and Belgrave Clinic, Tallaght Cross and Crumlin Medical Clinic, in Dublin.

Network collaborator, Professor Tom Fahey of the Royal College of Surgeons in Ireland, said: “We don’t know for sure which people with symptoms of the flu should be prescribed antiviral drugs, and nor do we know the cost-effectiveness of antivirals in terms of helping people return to normal activity levels. The ALIC4E trial aims to answer these important questions.”

ALIC4E is an initiative of the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium. Funded by the European Commission’s FP7 Programme, PREPARE was setup to support research organisations to respond rapidly to pandemics with clinical studies that can provide real-time evidence to inform the public health response.